FDA Changes Safety Label for Pediatric Prescription Opioid Medication

Prescription opioid cough and cold medicines that contain codeine or hydrocodone are being stripped of their indications to treat cough in kids, FDA announced Thursday (Jan. 11). The new label's safety warnings will be consistent with the labeling of other opioid-containing drug products, such as immediate-release opioid analgesics and extended-release and long-acting opioid analgesics. These changes include limiting the use of these agents to adults ≥18 years old, as well as the addition of new safety information regarding the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death to the Boxed Warning.

"We know that any exposure to opioid drugs can lead to future addiction", Gottlieb said.

Gottlieb added that the FDA is taking steps to assure parents that treating the common cold or cough is possible without prescription opioid medicine. The contraindication - FDA's strongest warning - alerted patients that codeine should not be used to treat pain or cough in children younger than 12 years old, due to ultra-rapid metabolism being reported in patients.

In a few states, codeine cough medicine is still available for over-the-counter (OTC) dispensing.

The FDA also recommended against the use of these medications by women who are breastfeeding. "Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits", the FDA said in announcing the new labeling. The administration advises parents children prescribed codeine or hydrocodone to talk their health care professional about alternate treatment options.

The company has recently ramped up its launch pace, even launching two missions from opposite coasts within about 48 hours. Additionally, a SpaceX rocket carrying supply missions to the International Space Station for NASA exploded in 2015.

The incendiary comments appear to have caused a deep rift between the former White House chief strategist and Trump. In response, the publisher moved the book's release date from next week to January 5, citing unprecedented demand.

Vibriosis causes about 100 deaths in the United States each year, according to the Centers for Disease Control and Prevention . During that time there were at least 72 infections, mostly caused by eating raw oysters, and 36 deaths.

At the announcement on Wednesday, Bill de Blasio declared that New York City is " standing up for future generations ". ExxonMobil spokesman Scott Silvestri says the company has made good faith attempts to address climate change.

Native Minnesotans named to the All-Star Game include rookie winger Brock Boeser of Vancouver and Winnipeg captain Blake Wheeler . He won gold at the 2014 U18 World Junior Championships, ranking tied for second among tournament defensemen in scoring.

Although flu season can start as early as October, this year, as usual, it's shifted into high gear in late December and January. Despite what has been reported about the flu vaccine's effectiveness, the CDC says it believes the "U.S.

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